Onward Medical (ONWD) investor relations material

Market need and company vision

• Spinal cord injury affects 9 million globally, with high lifetime care costs exceeding $5 million per tetraplegic patient.

• Technologies aim to restore hand function, mobility, and independence for those with spinal cord injuries.

• Three platforms: ARC-EX (external stimulator), ARC-IM (implanted system), and ARC-BCI (brain-computer interface) at various development stages.

• Over 10 FDA Breakthrough Device Designations and 150+ patents issued worldwide.

• Strategic investors include Ottobock and the Christopher Reeve Foundation.

Technology platforms and clinical progress

• ARC-EX is commercially available in the US and Europe, targeting hand function with a global TAM of $8 billion.

• Pivotal study showed 90% improved strength/function, 87% reported better quality of life, with benefits seen up to 34 years post-injury.

• ARC-IM, a fully implanted system, is in pivotal trials for blood pressure instability, showing positive results in all 14 initial patients.

• ARC-BCI enables thought-driven movement restoration; five humans have been implanted, with US clinical trials planned in 2–3 years.

• BCI technology secured exclusive rights and received FDA Breakthrough Device status.

Commercialization, sales, and reimbursement

• Over 70 ARC-EX systems sold to 60+ US clinics by Q3, with strong ongoing demand and thousands of inbound inquiries.

• US go-to-market strategy leverages a consultative sales team of therapists, focusing on 500 specialized clinics.

• Initial reimbursement targets VA, workers' comp, and self-pay, with Medicare coverage planned after real-world data is established.

• Revenue expected at $6–6.5 million in year one, rising to mid-teens (millions) in year two.

• Company is fully funded for 2026 milestones, with runway into 2027 after a €50 million financing round.